Releasable monitor with optical dose counter for a medicament inhaler

ABSTRACT

Some embodiments are directed to a device for monitoring patient usage of a medicament inhaler, being adapted to deliver doses of medicament, and including parts which move during the dispensing of a dose of medicament. The device includes a housing, for releasable attachment to the medicament inhaler, and an optical dose counter associated with said housing, being adapted to determine when a dose of medicament has been dispensed by transmitting optical signals through the medicament inhaler. The device is attachable to the medicament inhaler, and is subsequently operable without any modifications being required to be made to the medicament inhaler. The device may also include an electronic control module which is in communication with the optical dose counter, the electronic control module being adapted to monitor and/or store data relating to patient usage of the medicament inhaler.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/705,813, filed Dec. 5, 2012, which is a continuation of U.S.application Ser. No. 12/381,145, filed on Mar. 6, 2009, which claimspriority to New Zealand Patent Application No. 574666, filed Feb. 5,2009, the contents of each which are all hereby incorporated byreference in their entireties.

FIELD

This invention relates to improvements in or relating to medicamentinhalers. In particular, the invention relates to a device forreleasable attachment to a medicament inhaler, which monitors patientusage of the medicament inhaler. The invention may be particularlysuitable for use with medicament inhalers used for the treatment ofrespiratory diseases such as asthma, COPD, cystic fibrosis, andbronchiectasis. However, it is to be understood and appreciated that theinvention is not to be limited to such use. For example, the medicamentinhalers could be used to supply medicaments to treat diseases such asdiabetes, heart disease, and cancer. Furthermore, such medicamentinhalers could also be used to supply pain medicament, or medicaments totreat disorders such as erectile dysfunction and nicotine addiction. Theprior art and possible applications of the invention, as discussedbelow, are therefore given by way of example only.

BACKGROUND

The use of medicament inhalers for the treatment of diseases ordisorders is well known. Such inhalers are generally referred to asMetered Dose Inhalers (MDI).

A common type of MDI is what is known as a pressurised Metered DoseInhaler (pMDI). Such inhalers generally comprise a medicament canisterand an actuator. The medicament canister contains medicament underpressure and is designed to deliver a metered dose of medicament in theform of an aerosol spray. The actuator generally comprises asubstantially L-shaped hollow tube which has a first open end adapted toreceive the medicament canister, and a second open end which acts as amouth piece.

Medicament canisters for use with a pMDI generally have a spray stemextending from one end which is adapted to engage with a spray-directingelement housed within the actuator, and adjacent to the mouth piece ofthe actuator. When the canister is pushed down into the actuator, thespray stem and spray-directing element combine to direct a metered doseof medicament out through the mouthpiece and into the mouth of the user.

Another common type of MDI is what is known as a Dry Powder Inhaler(DPI). DPI's are generally in the form of a disc or grinder which may berotated, or otherwise actuated, in order to dispense a metered dose ofdry powder into an appropriate receptacle such as a mouthpiece. The drypowder may then be inhaled by the user, for example, by sucking stronglythrough the mouthpiece.

Further examples of medicament inhalers include delivery devices such asnebulisers and nasal sprays. Such delivery devices are generallydesigned to supply a dose of medicament in the form of a fine mist,which is directed either into the mouth or nasal cavity of a user.

Some medicament inhalers are kept on hand for use in a specific event oremergency. For example, if a person were to have a sudden asthma attack,they may reach for a medicament inhaler which contains what is generallyknown as a “reliever” medicament. A reliever medicament is fast actingand in most cases will relieve (or reduce the severity of) an asthmaattack, almost instantaneously.

Other medicament inhalers are designed for regular use in order toprevent an event such as an asthma attack and/or to manage or control adisease such as asthma. Such inhalers are generally known as“preventers” because the regular use of such inhalers serves to prevent(or minimise the likelihood of) an asthma attack. The regular use ofpreventer medicament by asthma sufferers is generally effective incontrolling the disease and/or preventing the vast majority of asthmaattacks. Commonly, preventer medicament for asthma sufferers is takentwice a day, usually at a set time in the morning and in the evening.

There are now also available “combination” medicament inhalers whichcombine both a reliever and preventer medicament.

Studies have shown that many people overuse their reliever medicament,for example by using it when only mildly short of breath. The overuse ofa reliever medicament has the potential to reduce the effectiveness ofthe medicament, which may render the medicament less effective in timesof real need, for example during a severe asthma attack.

Moreover, a patient's increased use of a reliever medicament over aperiod of time may be indicative of a pending exacerbation event.

It would therefore be of advantage if there was available a device formonitoring patient usage of a reliever medicament inhaler in order todetermine any potential overuse and/or for predicting a potentialexacerbation event, prior to the event occurring.

A problem or difficulty associated with the use of preventer (or“combination”) medicament inhalers is poor medicament compliance. Thatis, many studies have shown that users frequently do not take theirmedicament at the predetermined or prescribed times and/or in therequired amounts.

The consequences of poor medicament compliance are reduced diseasecontrol, lower quality of life, lost productivity, hospitalization andavoidable deaths.

Not only is compliance to preventative medicaments typically low, but ithas also been shown that actual compliance by a user is lower than thesame user's estimated compliance.

In order to address these problems and difficulties, there are availablea number of compliance monitoring devices for use with medicamentinhalers.

Virtually all compliance monitoring devices incorporate dose countingmeans. In a general sense, dose counting means provide the simplestembodiment of a compliance monitor, as the dose count may indicate thenumber of medicament doses delivered and/or the number of medicamentdoses remaining in the medicament inhaler (the latter known as an“absolute dose counter”). The doses dispensed or remaining may also bedisplayed on a dosage counter, such as an LCD display, housed on themedicament inhaler.

The earliest dose counting mechanisms for pMDI's usually incorporatedmechanical dose counting switch mechanisms such as levers or springs ortrigger rods—which were mechanically actuated by movement of thecanister within the actuator when a dose of medicament was dispensed.For example, see U.S. Pat. No. 4,817,822 (Rand et al) and U.S. Pat. No.5,020,527 (Dessertine).

There are several problems associated with the use of such mechanicaldose counting means. Firstly, the mechanical switch mechanisms includemoving parts which may suffer wear and tear or otherwise deteriorateover time. Secondly, the switch mechanisms could break off and enter themedicament delivery pathway, and be inadvertently swallowed by the user.Thirdly, the mechanical switch mechanisms, which are commonly housedinside the actuator, can change the airflow characteristics of theinhaler, which may adversely impact on the medicament deliveryperformance of the inhaler. Lastly, mechanical switch mechanisms may beinadvertently triggered by the user, for example during washing of theactuator body to clean away any built up medicament residue (which mustbe done from time to time).

In recognition of some of the above problems or difficulties, U.S. Pat.No. 6,601,582 (Rand et al—but referred to herein as “GSK”) describes amechanical dose counter which is integrally formed on the medicamentcanister. However, a disadvantage associated with GSK is that theincorporation of a dose counting mechanism into each and everymedicament canister adds cost to the end user. Moreover, given that eachcanister typically contains a one month supply of medicament, it iseconomically and environmentally wasteful to supply and then discardsuch technology with each month's medication.

More recent dose counting mechanisms incorporate electronic countingmeans. For example, see U.S. Pat. No. 5,544,647 (Jewettt et al). U.S.Pat. No. 6,202,642 (McKinnon et al) and US Patent Publication No.2005/0028815 (Deaton et al).

However, most electronic dose counting mechanisms also rely on thecanister physically engaging with a switch mechanism for the purpose ofclosing an electrical switch (to indicate a dosage count of one). Forexample, in order to record a dosage count of one. Jewett includes amicroswitch (42) which is physically engaged by the leading edge (19) ofa sleeve (17) which is attached to the canister (16)—see FIG. 1.Similarly, Deaton utilises a ramp portion (42) which is physicallyengaged by the shoulder (26) of the canister (14) during the dispensingof a dose of medicament—see FIGS. 22a and 22 b.

Hence, because such electronic dose counting means also include movingparts, these parts are likewise susceptible to wear and tear and/ordeterioration over time (they may also be susceptible to breaking offand/or interfering with the airflow within the inhaler).

Furthermore, the fitting of mechanical or electronic dose counters to aninhaler usually requires modifications to the inhaler, for example thedrilling of a hole in the side of the actuator or the attachment of acap or sleeve to the canister. The fitting of such dose counters to aninhaler can therefore be a fiddly or time consuming operation.

More importantly however, any modifications made to the actuator (orcanister) have the potential to interfere with the airflowcharacteristics within the actuator, possibly affecting theeffectiveness of delivery of a dose of medicament. This may result inthe patient not receiving the required amount of medicament in order totreat the disease.

Any modifications made to the actuator may also be prone to disruptionwhen washing the actuator. This may subsequently result in inaccuratedose counting or compliance monitoring (Jewett and Deaton address thisissue by housing the compliance monitoring means within a hermeticallysealed housing—which increases cost and manufacturing complexity).

Most mechanical or electronic dose counters are designed to be absolutedose counters. That is, when a new medicament canister is placed in theactuator, the counters are either manually or automatically set to thenumber of doses remaining in the full canister (typically around 120doses which usually comprises one month's supply of a preventermedicament). The GSK device referred to previously is an example of anabsolute dose counter (but formed on the canister, rather than theactuator).

Every time a dose of medicament is dispensed, the dose counter serves toreduce the displayed number of doses remaining by one. Hence a user isable to keep track of the number of doses remaining in the canister, andcan therefore ensure he/she has a replacement canister at hand prior towhen the first canister is due to run out.

A disadvantage associated with absolute dose counters is that they arededicated to only one canister at a time. Hence, they are not able tomonitor the ongoing compliance characteristics of a user over a periodof time which may involve the user going through many canisters ofmedicament. Moreover, absolute dose counters are not able to monitor aperson's usage over all four seasons to determine useful informationsuch as any seasonal fluctuations. Absolute dose counters are also notable to monitor the ongoing compliance characteristics of a user shouldthey change medications when only half way through an existing canister.

Presently available electronic compliance monitoring devices alsoinclude means to record a range of compliance data, in addition to dosecounting. For example. Dessertine includes a timer to indicate timebetween doses. McKinnon includes an electronic module to record date andtime as well as more comprehensive patient usage information.

Most electronic compliance monitoring devices are integrally formed withthe inhaler, usually by being mounted on, or integrally formed with, theactuator body (eg, see Jewett and Deaton). This presents its owndifficulties or limitations.

Firstly, because the compliance monitoring device is integrated with themedicament inhaler, it cannot generally be reused for longer than thelife of the inhaler. Furthermore, compliance monitoring technology, andespecially electronic compliance monitoring technology, adds cost whenintegrated into each and every inhaler.

However, reusing an actuator over more than one medicament canister canlead to residual medicament build-up that reduces the quantity of thedrug delivered by the inhaler, and can also change the depositionproperties of the aerosol particles, meaning patients get lessmedication.

Furthermore, repeatedly discarding the plastic and electronic compliancemonitoring technology also creates an environmental sustainabilityproblem that needs to be addressed. Additionally, as not all diseasesufferers exhibit poor disease control or poor compliance, it iswasteful to provide such features embedded into each inhaler of a giventype.

Perhaps partly in recognition of the above disadvantages associated withinhalers with integrally formed compliance monitoring means, McKinnondescribes an electronic module which is releasably attachable to asleeve which is fitted to the actuator. However, the removal of theelectronic module from the sleeve renders the sleeve inoperable, whichmust then be removed and discarded, which is wasteful and expensive.Furthermore, the electronic module must be reprogrammed once it has beenremoved from the sleeve and prior to the module being fitted to anothersleeve. Moreover, the fitting of the sleeve and electronic module to aninhaler is a time consuming and complex operation—which may presentsignificant operational difficulties, especially for young children, theelderly or people of reduced mental capacity. Furthermore, the sleeve ispreferably designed for attachment to only one specific brand ofactuator. Hence, the McKinnon device cannot be used across a range ofdifferent actuators.

U.S. Pat. No. 5,564,414 (Walker et al) describes the concept of aremovable sleeve designed to fit the body of a manufacturer's inhaler.However, Walker uses a mechanical counting mechanism (an externalplunger-type trigger rod), which has the same disadvantages generallyassociated with mechanical counting means, as referred to previously.

PCT/US 2008/052869 (Levy et al) describes a sleeve housing which isreleasably attachable to an actuator body. The sleeve housing includeselectronic monitoring apparatus and the device is designed to monitorusage in order to predict an exacerbation event. However. Levy relies ona counting means which requires attachment of a cap to the canisterwhich is adapted to engage with a dose-dispensing sensor during thedelivery of a dose of medicament. Hence, Levy requires modifications tothe inhaler prior to being able to be used—which has the potential, overtime, to interfere with the effectiveness of the inhaler to properlydeliver medicament.

Levy also discloses the use of wireless technology to transmitcompliance data to a remote device such as the laptop of a healthprofessional. This data may be transmitted in real time or atpredetermined set times.

Furthermore, the sleeve components described in McKinnon. Walker andLevy would not be able to be used in relation to a medicament canisteralready fitted with an absolute dose counter, eg the GSK device referredto previously.

Another problem associated with integrated electronic compliancemonitoring devices is that many drugs are regulated and require exactactuator conformity. That is, there should be no modifications made tothe actuator structure as any modifications may distort the reliabilityof the delivery of the medicament. Moreover, physicians, researchers,insurance companies, and so on, would not want to risk (for example, interms of liability) the possibly of affecting the proper delivery of themedicament through these dedicated electronic instruments without thesame assurance of proper drug delivery as with the commercial actuatorprovided by the drug manufacturer.

Having regard to the foregoing, it would therefore be of advantage ifthere was available a device for monitoring patient usage of amedicament inhaler which was releasably attachable to range of differentmedicament inhalers, and without any modifications being required to theinhaler.

BRIEF SUMMARY OF THE INVENTION

It is an object of the present invention to provide an improvedmedicament inhaler which goes some way towards addressing theaforementioned problems or difficulties, or which at the very leastprovides the public with a useful choice.

It is a further object of the present invention to provide a releasablyattachable device for a medicament inhaler which goes some way towardsaddressing the aforementioned problems or difficulties, or which at thevery least provides the public with a useful choice.

Throughout this specification unless the text requires otherwise, theword ‘comprise’ and variations such as ‘comprising’ or ‘comprises’ willbe understood to imply the inclusion of a stated integer or step orgroup of integers or steps but not the exclusion of any other integer orstep or group of integers or steps.

Throughout this specification, the term “patient” or “user”, when usedin relation to a medicament inhaler, is to be understood to refer to anyperson that uses a medicament inhaler.

According to one aspect of the present invention, there is provided adevice for monitoring patient usage of a medicament inhaler, saidmedicament inhaler being adapted to deliver doses of medicament, andwherein said medicament inhaler includes parts which move during thedispensing of a dose of medicament,

wherein said device includes:

a) a housing, said housing being releasably attachable to saidmedicament inhaler.

b) an optical dose counter associated with said housing, said opticaldose counter being adapted to determine when a dose of medicament hasbeen dispensed by transmitting optical signals through the medicamentinhaler,

c) an electronic control module associated with said housing, saidelectronic control module including, or being in communication with,said optical dose counter,

d) said electronic control module being adapted to monitor and/or storedata relating to patient usage of said medicament inhaler, thearrangement and construction being such that said device is attachableto said medicament inhaler, and subsequently operable, without anymodifications being required to be made to said medicament inhaler.

The medicament inhaler may be any suitable medicament inhaler capable ofdelivering a dose(s) of medicament, and preferably (but not exclusively)a metered dose of medicament. For example, the medicament inhaler may bea pMDI, a DPI, a nebuliser or a nasal spray.

Preferably, the medicament inhaler may include part(s) which move duringthe delivery of a dose of medicament. For example, in the case of apMDI, the moving part would be a medicament canister, which moves withinan actuator during the dispensing of a dose of medicament. Likewise, aDPI may include a rotating disk, which moves in order to place a dose ofdry medicament into a compartment, for subsequent inhalation by thepatient.

The device may be utilised for use with inhalers that contain apreventer medicament and/or inhalers that contain a combinationmedicament. The device may therefore serve as a compliance monitor inrespect of the patient usage of such inhalers.

The device may also be used to monitor patient usage of a relievermedicament in order to determine any potential overuse and/or forpredicting a potential exacerbation event, prior to the event occurring.

The device may preferably include a housing which may be releasablyattachable to an inhaler.

An advantage associated with having a releasably attachable housing isthat the device may be reused by the patient. For example, when aninhaler exhausts its supply of medicament, the device may be removedfrom the inhaler and releasably fitted to either another inhaler or thedevice may remain on the same inhaler, but with a replacement supply ofmedicament added. Furthermore, any data being collected by the device inrelation to the patient usage of the inhaler may therefore be continuousover a period of time that may include the patient going through manysupplies of medicament (either with the same inhaler or across a rangeof inhalers and/or medicaments). Hence, a comprehensive amount ofpatient usage data may be obtained over a significant period of time.

The releasably attachable housing may preferably be attachable to theinhaler, and subsequently operable, without any modifications beingrequired to the inhaler. That is, the inhaler simply sits partially orfully within the housing of the device.

A significant advantage of such an arrangement is that the device doesnot in any way interfere with, or otherwise affect, the ability of theinhaler to administer medicament. This compares favourably with theprior art devices referred to previously, most of which requiremodifications to the inhaler in order to be fitted and/or operable. Forexample, modifications may include the drilling of a hole into the sideof the inhaler or the fitting of a cap to a medicament canister—both ofwhich have the potential to interfere with the airflow characteristicswithin the inhaler and/or adversely affect the ability of the inhaler todispense medicament.

Furthermore, the attaching of the housing to the inhaler preferably doesnot require the use of any tools in order to be fitted (for example, thehousing is not releasably screwed into or onto the inhaler). Instead,the inhaler to be used with the present invention is simply placedwithin the housing of the device.

The housing may be of any suitable size, shape or configuration asrequired or desired, or as dictated by the type or configuration of theinhaler.

In one embodiment, the housing may be in the form of a sleeve adapted tobe fitted around the outside of the inhaler.

The housing may be adapted to partially enclose the inhaler and/or toclip onto the inhaler. For example, the housing may be in the form of asubstantially U-shaped sleeve adapted to clip snugly around the outsideof the inhaler. In such an embodiment the housing may be provided withadditional means to help secure the housing to the inhaler, for exampleby the use of ties, straps or clips.

In another embodiment, the housing may be adapted to fully encircleand/or fully contain the inhaler.

The housing may be provided with a hinged portion, which, when open,allows the inhaler to be placed within the housing, and which, whenclosed, serves to retain and/or secure the inhaler substantially withinthe housing. In such an embodiment, the hinged portion may be providedwith closure and release means, to secure the hinged portion in a closedposition, and release the hinged portion from said closed position,respectively. For example, the closure and release means may be providedby a suitable fastener such as a VELCRO brand fastener, or alternativelyby a latch-type mechanism. The closure and release means may also beprovided by the closing edge of the hinged portion having a male portionwhich is adapted to releasably engage with a corresponding femaleportion formed in the housing proper.

The housing may be made of any suitable material although a plasticsmaterial may be preferred as it is relatively light, and may beconveniently and inexpensively mass produced, for example by injectionmoulding technology.

The housing may be substantially opaque, translucent or transparent. Forexample, the housing may be substantially opaque and of the same colouras a particular manufacturer's range of inhalers to which it is intendedto be fitted.

Alternatively, the housing may be substantially transparent (ortranslucent). This may have practical implications given that the innerworking of the housing and/or the inhaler may be inspected or monitoredthrough the housing. Such an embodiment may also have some aestheticappeal given that the inner workings of the housing may be viewed.

The optical dose counter may preferably be adapted to determine when adose of medicament has been dispensed by transmitting optical signalsthrough the inhaler.

Preferably, the optical dose counter transmits (and receives) opticalsignals from a position outside of the inhaler. Hence, the optical dosecounter does not impact, in any way, on the ability of the medicamentinhaler to dispense medicament.

Preferably, the optical dose counter may be incorporated within thehousing of the device. Alternatively the optical dose counter may behoused on the outside of the housing.

An advantage of utilising an optical dose counter generally is that thedose counter does not require any physical connection with themedicament inhaler in order to be able to register when a dose has beendispensed. Furthermore, the recording of a dose of medicament does notrequire any moving parts such as mechanical or electrical switches.

The optical dose counter may utilise any type of light from within theelectromagnetic spectrum. For example, the dose counter may utiliseinfrared light. Alternatively, the dose counter may utilise visiblelight.

According to another aspect of the present invention there is provided adevice for monitoring patient usage of a medicament inhaler,substantially as described above, wherein said optical dose counterincludes:

a) at least one light transmitter able to transmit an optical signal,

b) at least one light receiver able to receive an optical signal,

c) the arrangement and construction being such that movement of thepart(s) within the medicament inhaler during the delivery of a dose ofmedicament alters the optical signal(s) whereby the optical dose counteris able to determine that a dose has been dispensed.

In one embodiment, the light receiver(s) may be positioned substantiallyopposite the light transmitter(s) in order to receive a substantiallydirect beam of light, for example a laser beam. In such an embodiment,the movement of part(s) within the inhaler during the dispensing of adose may temporarily block the beam of light, thus enabling the dosecounter to register that a dose of medicament has been dispensed.

In an alternative embodiment, the light transmitter(s) may transmit anormal beam of light, which will generally disperse outwardly from thepoint of transmission. The movement of part(s) within the inhaler duringthe dispensing of a dose will therefore affect the light signal, forexample by the light reflecting off the part(s) as they move. This willalter the intensity of light being received by the light receiver(s),thus enabling the dose counter to register that a dose of medicament hasbeen dispensed. In such an embodiment, it is not necessary that themoving part(s) actually block the light signal to enable a dose to bedetected and/or counted. Hence, the light transmitter(s) and lightreceiver(s) need not necessarily be positioned substantially oppositeeach other. It is also possible that the light transmitter(s) and lightreceiver(s) could be positioned next to each other or side by side.

One skilled in the art will appreciate that the sensitivity of theoptical dose counter could be calibrated to ensure that the opticalcounter only registers when a dose has been dispensed, as compared toother instances of movement of the part(s) within the inhaler, forexample any movement caused when the inhaler is bumped or being carriedaround in the bag of a user.

The device may also include an audio sensor to detect sound associatedwith movement of the medicament container during delivery of a doseand/or sound associated with the inhalation of the medicament by thepatient. In such an embodiment, the optical dose counter may be adaptedto receive information gathered by the audio sensor, and use this toconfirm its own data that a dose of medicament has been dispensed.Furthermore, the optical dose counter may be configured to only recordthat a dose has been dispensed when the optical dose sensor and theaudio sensor both determine that a dose has been dispensed. That is, ifthe audio sensor determined that a dose had been dispensed, but theoptical dose counter did not (or vice versa), then a dose may not berecorded.

It is also envisaged that the optical dose counter may be adapted orable to monitor for non-dose counting events, for example:

1. When a medicament container has been removed from and/or placed intothe inhaler.

2. When an inhaler has been removed from and/or placed into the housingof the device.

3. The amount of medicament remaining in the medicament container.

For Items 1 and 2 above, the removal of the medicament container orinhaler will affect the light signal, for example by the lightreflecting off the part(s) as they move. This will alter the intensityof light being received by the light receiver(s), thus enabling theoptical dose counter to register and/or record that one or both of theseevents has occurred. Moreover, the removal of the medicament containerwill alter the light intensity in a different way to the removal of theinhaler proper, and hence the optical dose sensor may be calibrated beable to differentiate between these two events and/or determine whichevent has occurred.

For Item 3 above, the optical dose counter may be able to determine theamount of medicament remaining in the medicament container by monitoringthe ongoing intensity of light passing through the medicament container.The optical dose counter and/or electronic control module may be furtheradapted to sound an alert when the level of medicament remaining reachesa certain threshold.

The optical dose counter may also be provided with its own memory (andreal time clock) in order to store any counting or non-counting data.

The electronic control module may preferably be housed within thehousing of the device. Alternatively, the electronic control module maybe housed on the outside of the housing.

The electronic control module may preferably include, or be incommunication with the optical dose counter. Hence, the optical dosecounter may be a stand alone unit in communication with the electroniccontrol module, or it may be deemed to be incorporated within theelectronic control module.

It is envisaged that both the optical dose counter and/or electroniccontrol module may be housed within a hermetically sealedcompartment(s), for example to minimise exposure to dust or medicamentparticles or to enable the device to be washed from time to time.

The electronic control module may preferably include, or be incommunication with, means for monitoring and/or storing data relating topatient usage of the medicament inhaler. The means for storing data may,for example, include a ROM or RAM memory storage means.

The electronic control module may further include processing means toenable the electronic control module to perform operations on thepatient usage data. The result of any operations performed on thepatient usage data may be stored in the memory associated with theelectronic control module.

The electronic control module may preferably include a user interface toallow the patient to access any data recorded or received by theelectronic control module, and/or to change the settings of the device.Preferably, the user interface may include a visible screen, such as aLCD screen, and at least one control button.

The electronic control module may preferably include a dose counterdisplay for viewing by the patient, for example on a LCD screen. ThisLCD screen may be the same as that used with the user interface. In suchan embodiment, the dose counter display may temporarily disappear whenthe patient is using the user interface to change the settings of thedevice, only to reappear once the patient has finished, for exampleafter a predetermined length of time has passed since the user interfacewas last used.

Alternatively, the dose counter display may have its own dedicateddisplay.

Preferably, the dose counter display may be updated each time a dose ofmedicament is dispensed.

The device may be used by the patient to serve as an absolute dosecounter. In such an embodiment, and for example, the patient may utilisethe user interface to choose this option and then enter the total numberof doses remaining to be dispensed by the medicament, this number beingdisplayed by the dose counter display. After the dispensing of each doseof medicament by the inhaler, the dose counter display will reduce thenumber of doses remaining by one.

The device may also be used by the patient to serve as a non-absolutedose counter. In such an embodiment, and for example, the patient mayutilise the user interface to choose this option and then reset the dosecounter display counter to zero. After the dispensing of each dose ofmedicament by the inhaler, the dose counter display will increase thenumber of doses taken by one. Furthermore, the patient may keep anongoing total of the number of doses of medicament dispensed over a setperiod of time, and in relation to a number of medicament containers,rather than just in relation to one supply of medicament.

Preferably, the electronic control module includes, or is incommunication with, a means to record the date and/or time of each doseof medicament, for example a real time clock. Furthermore, the real timeclock may also be used to date/time stamp any other events, for examplewhen the processor performed certain operations, or when an alarm wasraised or sent, or when the inhaler was removed from the device, and soon.

The electronic control module may preferably include notification meansto notify the patient of a particular event. For example, thenotification means may include a means for reminding the patient to takea dose of medicament should the electronic control module determine orreceive notification that the patient has not taken a dose within apredetermined time. Likewise, the notification means may be adapted toalert the patient to a situation where they have taken too much of amedicament over a predetermined time period, which may be indicative ofan exacerbation event.

The notification means may preferably include, or be in communicationwith, a visual display and/or an audio output means.

For example, a visual notification display may appear on the userinterface, perhaps as a flashing message to draw attention to itself.Alternatively, or additionally, an audio output such as an alarm may bemade through the audio output means. Different alarms may be sounded fordifferent alerts, or if a patient has continually forgotten to takehis/her medicament. In such an embodiment, it may also be possible forthe patient to mute the audio output means, for example if the patientwas in a meeting or a movie theatre.

A further example of a notification means that may be used with thepresent invention is that described in our granted NZ Patent No. 540250.

The electronic control module may preferably include, or be incommunication with, a wireless transmitter to enable the wirelesstransmitting of patient usage data. The data may preferably betransmitted to a public access network such as the internet.Alternatively, the data may be transmitted to a private access networksuch as dedicated computer or intranet.

The wireless transmitter may preferably be in the form of a cell phonechip housed within the electronic control module (or the housing). Anadvantage associated with the present invention is that the significantcost of installing a cell phone chip may be mitigated by the fact thatthe device is reusable and has an indefinite lifetime. That is, onereason cell phone chips (or like wireless technology) are not usuallyincluded in presently available monitoring devices is because suchmonitoring devices are not designed to be reusable, and hence the costof installing a cell phone chip in such a short-lived, disposable deviceis prohibitive. The present invention therefore overcomes this problembecause the device is designed to be reusable over a significant timeperiod, and across a range of different inhalers.

The wireless transmitter may preferably be adapted to transmit data to athird party such as a medical practitioner or to a parent or care giver.

The wireless transmitter may preferably be adapted to transmit the datain real time.

Alternatively, the wireless transmitter may be adapted to transmit dataat a predetermined time(s), or in response to when a predeterminedcondition eventuates. For example, if too many doses of medicament havebeen dispensed over a set time period this may be indicative of animpending exacerbation event. An appropriate warning may then be made toeither the patient or a third party such as a care giver or medialpractitioner. Likewise, if the patient has forgotten to take theirmedicament a certain number of times and over a predetermined length oftime, an appropriate warning may likewise be transmitted to such a thirdparty.

The electronic control module may also preferably include, or be incommunication with, a wireless receiver (or transceiver) to enable thewireless receipt of data or instructions. In such an embodiment, and forexample, the wireless receiver may be utilised to enable the patient (ora third party) to send instructions from a remote location or electronicdevice to change one or more of the settings of the device, or to accessthe data stored within the device. Such an embodiment may provide analternative to the patient using the user interface and/or may enablethe patient to have more options regarding the choice of (or change to)settings of the device. The wireless receiver may also be utilised toreceive notifications and possibly sound an alert or alarm. For example,if a third party such as a parent or medical practitioner had receiveddata from the device which indicated that an exacerbation was imminent,that third party may be able to transmit a warning to the device, forexample by the use of a laptop or mobile phone.

The device may alternatively, or additionally, be provided with a wiredport to enable the transmission of data or instructions between thedevice and another electronic device.

The optical dose counter may be adapted to determine deterioration inthe inner surfaces of the medicament inhaler, for example deteriorationcaused by build up of medicament residue, which should be cleaned off toensure the ongoing optimal performance of the inhaler. The means fordetermining this may be based on changes in the light levels reflectedfrom the inner surfaces of the medicament inhaler over time. Namely, thelight transmitter(s) of the optical dose counter will be continuouslytransmitting light through the inhaler when the medicament inhaler is inits rest position, that is, in a non-dose dispensing configuration. Overtime, the light receiver(s) may detect a slight variation in the qualityof light reflected off the inside walls of the inhaler, which maysuggest the inhaler may need to be cleaned and/or replaced once apredetermined variation has been reached. One such a predeterminedvariation has been reached, an audible or visual alarm may be instigatedto alert the patient to the deteriorating condition of the inhaler.

It may be appreciated that the device, which is the subject of thepresent application, may be utilised across a range of differentmedicament inhalers of similar design. For example, the device may bedesigned whereby it was able to be used across a certain range (such asone company's range) of pMDI or DPI inhalers which were of similar sizeand/or which shared similar design features. Hence, a patient may beable to utilise the device for ongoing usage monitoring or complianceif, for example, they changed medicament (which came with a differentinhaler), but whereby the different inhaler was still able to beutilised with the device. This may be of particular advantage duringclinical trials where the ongoing monitoring of a patient is beingundertaken over a considerable time period, and perhaps whereby thepatient changes medicament half way through the trial.

The device may also be adapted to be operationally effective whenattached to a medicament inhaler which already includes an inbuilt dosecounter, for example the GSK device referred to previously. In such anembodiment, the housing of the device may be provided with cut awayportions so that the inbuilt dose counter may still be viewed.

The description of a preferred form of the invention to be providedherein, with reference to the accompanying drawings, is given purely byway of example and is not to be taken in any way as limiting the scopeor extent of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1: is a front perspective view of one possible embodiment of thepresent invention.

FIG. 2: is a front perspective view of the embodiment illustrated inFIG. 1, when attached to a pMDI medicament inhaler.

FIG. 3: is a side view of the embodiment illustrated in FIG. 2.

FIG. 4: is a cut-away view of the embodiment illustrated in FIG. 3.

FIG. 5: is cut-away view illustrating one possible embodiment of anoptical dose counter for use with the present invention, when amedicament canister is in a rest position.

FIG. 6: is a view of the embodiment illustrated in FIG. 5, with themedicament canister in a dose dispensing position.

FIG. 7: is a rear view of a prior art medicament canister,

FIG. 8: is a rear view of the prior art medicament canister illustratedin FIG. 7, when housed within the embodiment illustrated in FIG. 1,

FIG. 9A: is a perspective view of another possible embodiment of thepresent invention, when attached to a DPI medicament inhaler,

FIG. 9B: is front view of a DPI medicament inhaler housed within theembodiment illustrated in FIG. 9A,

FIG. 9c : is a perspective view of the embodiment illustrated in FIG. 9.

FIG. 10: is a simplified system block diagram showing one possibleembodiment of an electronic control module and optical dose counter foruse with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Having regard to the drawings, there is shown a device, generallyindicated by arrow 1, for monitoring the patient usage of a medicamentinhaler, generally indicated by arrow 2 (see FIG. 2).

The device 1 includes a housing, generally indicated by arrow 3, forreleasable attachment to the inhaler 2. The housing 3 is adapted tofully encircle and/or fully contain the inhaler 2.

The inhaler 2 is a pMDI inhaler which includes an actuator 4 and amedicament canister 5.

The housing 3 is comprised of an injection moulded plastics material andis substantially translucent in appearance.

The housing 3 is provided with a main body portion 6 and a hinged bodyportion 7.

The main body portion 6 is substantially hollow and includes an interiorportion 8 which is adapted to substantially match the exteriorconfiguration of the inhaler 2, whereby the inhaler 2 may be snuglyretained within the interior portion 8 of the main body portion 6. Themain body portion 6 also includes lower ledge portions 9, upon which theunderside 10 of the actuator 4 rests, once the inhaler 2 has been placedwithin the main body portion 6.

The hinged portion 7 in FIG. 1 is shown in an open position which allowsthe inhaler 2 to be placed into the interior portion 8 of the main bodyportion 6. Once the inhaler 2 has been placed in the main body portion6, the hinged portion 7 is closed, as shown in FIG. 2. The hingedportion 7 is releasably secured to the main body portion 6 by the use ofa latch (not shown).

It may be seen from the drawings that the housing 3 is releasablyattachable to, or around, the inhaler 2, and subsequently operable,without any modifications being required to the inhaler 2. The inhaler 2may be operated as normal once retained within the device 1.

Furthermore, the attaching of the housing 3 to or around the inhaler 2does not require the use of any tools in order to be fitted; instead theinhaler 2 is simply placed within the housing 3 of the device 1.

The device 1 includes an electronic control module 11 (not physicallyshown, but represented in FIG. 10) housed within a side 12 of thehousing 3. The electronic control module 11 is adapted to monitor and/orstore data relating to patient usage of the inhaler 2.

The side 12 of the housing 3 includes a user interface, generallyindicated by arrow 13. The user interface 13 allows the patient toaccess data recorded or received by the electronic control module, andalso to change the settings of the device 1. The user interface 13includes operational buttons 14 and a LCD display 15. One of theoperational buttons 14 may be an on/off switch.

The device 1 includes an optical dose counter, generally indicated byarrow 16 (see FIG. 4). The optical dose counter 16 is housed within thehousing 3, and is in electronic communication with the electroniccontrol module 11 (see FIG. 10). The optical dose counter 16 is adaptedto determine when a dose of medicament has been dispensed by the inhaler2, by transmitting optical signals through the inhaler 2, and from aposition outside of the inhaler 2 (the operation of the optical dosecounter 16 is described in more detail later).

Having regard to FIG. 4, the medicament canister 5 includes a spray stem20, which is adapted to engage with the spray-directing element 21formed integrally within the actuator 4.

When a patient wishes to dispense a dose of medicament, he/she placestheir mouth over the mouthpiece 17 of the actuator 2, and presses downon the top 18 of the medicament canister 5—in the direction shown byarrow 19. This has the effect of pushing the spray stem 20 into thespray directing element 21, which releases a metered dose of medicament,and which is directed out of the mouthpiece 17 and into the mouth of thepatient. The patient will generally inhale deeply at the same time thatthe medicament is dispensed so that the medicament is inhaled into thelungs of the patient.

FIGS. 5 and 6 show the operation of the optical dose counter 16.

FIG. 5 shows the canister 5 in the non-dispensing, or rest position,whereas FIG. 6 shows the canister 5 in the position it would be whendispensing a dose of medicament.

Having regard to FIG. 5, it may be seen that the optical dose counter 16includes a light transmitter 22 housed within the housing 3 on one sideof the actuator 4, and a light receiver 23, housed within the housing 3on the opposite side of the actuator 4.

The light transmitter 22 is adapted to constantly transmit a beam ofinfrared light 24, which disperses outwardly from the point oftransmission, as shown. An alternative arrangement may be to have thelight transmitter 22 transmit a strobe.

The outwardly dispersing nature of the beam of light 24, occursnaturally, but this may also be accentuated by diffraction caused by thebeam of light 24 passing through the outside of the actuator 4.

The light transmitter 22 may preferably transmit a continuous beam oflight 24.

The light receiver 23 is constantly monitoring receipt of the beam oflight 24 from the light transmitter 22. In a preferred embodiment, thelight receiver may take a reading of the beam of light 24 approximately30 times per second. Alternatively, other reading times may be utilisedso long as the readings are frequent enough to detect movement of thecanister 5 during the dispensing of a dose of medicament—the movementtime of the canister (or dispensing time) is typically around 100milliseconds.

When the canister 5 is in the rest position, as shown in FIG. 5, thecanister 5 remains immobile within the actuator 4. The characteristics(such as intensity and direction) of the beam of light 24, as it passesthrough the actuator 4, are therefore not affected in any significantway. The light receiver 23 constantly monitors this.

However, when a dose of medicament is dispensed by the canister 5, asshown in FIG. 6, the movement of the canister 5 within the actuator 4has the effect of changing the characteristics of the beam of light 24,and this is noted by the light receiver 23—and hence the optical dosecounter 16 is thus able to determine that a dose has been dispensed.

The optical dose counter 16 is electronically connected to theelectronic control module 11 (see FIG. 10), so that data relating to thedispensing of doses by the optical dose counter 16 may be communicatedto the electronic control module 11, where it may be stored in memory,and also have other patient usage data associated with it, for example,date and time.

It may be seen from FIGS. 5 and 6 that the optical dose counter 16 isable to determine when a dose of medicament has been dispensed withoutimpacting in any way whatsoever on the operation of the inhaler 2 or onthe medicament delivery channel (namely the inside of the actuator 4 andmouthpiece 17). This is because the optical dose counter 16 is housedwithin, and operable from, a position outside of the actuator 4.Furthermore, the use of light to record the dispensing of a dose isnon-intrusive, and does not involve or require any physical connectionwhatsoever with the moving parts 4 (canister 5 and spray stem 20) withinthe actuator 4 during the dispensing of a dose. This is a significantadvantage of the present invention over and above the prior art devicesreferred to previously.

The electronic control module 11 is represented in the simplified systemblock diagram of FIG. 10.

The electronic control module 11 includes a central processor/controllerunit 25. The processor/controller unit 25 is adapted to control andmanage the overall operation of the device 1, as well as beingresponsible for processing or performing operations on the data.

For example, the electronic control module may be able to monitor and/orrecord the date/time of events such as the opening and/or closing of thehinged portion 7 of the housing 3; the replacement of the battery: whenany alarm notifications were made and whether the patient received themor responded to them; when a canister has been removed and/or replaced,and so on.

The electronic control module 11 is in electronic communication with theoptical dose counter 16, as shown in FIG. 10.

The electronic control module 11 includes a real time clock 26, which isable to note the date and time of each dose of medicament dispensed bythe inhaler 2. Furthermore, the time may be displayed on the LCD display15, if required.

The electronic control module 11 includes a power management system 27.The power 25 management system 27 includes a battery (not shown), andmay also include warning features whereby if the battery is getting low,the patient maybe alerted to this. The battery may be a replaceablebattery or a rechargeable battery.

The electronic control module 11 includes a memory 28 for storingpatient usage data, or any other data relating to the use of the device1. The memory, for example, may be RAM and/or ROM.

The electronic control module 11 includes a notification means whichincludes an audio/visual output 29. The audio output is in the form of asmall speaker (not shown) and the visual output is in the form of asecond small LCD screen (also not shown).

The audio/visual output 29 is in communication with the centralprocessor/controller 25 and is adapted to notify the patient of aparticular event. For example, audio/visual output 29 may sound an alarmto remind the patient to take a dose of medicament should it bedetermined that the patient has not taken a dose within a predeterminedtime. Likewise, the audio/visual output 29 may be adapted to alert thepatient to a situation where they have taken too much of a medicamentover a predetermined time period, which may be indicative of anexacerbation event. Furthermore, the notification means and audio/visualoutput may combine to sound alerts for any particular event, such as adose having been recorded (a beep may sound for example), the dosecounter reaching a predetermined number, and so on.

The electronic control module 11 includes a user interface 13, whichincludes operational buttons 14 and a LCD screen 15 (see FIG. 3). Thepatient may utilise the user interface to change the operationalsettings of the device 1.

The electronic control module 11 includes a wireless transmitter andreceiver to enable the wireless transmitting and receiving of data orinstructions. The wireless transmitter/receiver is an integratedcomponent and is represented as a transceiver 30 in FIG. 10. Thetransceiver 30 is essentially a means to allow the device to operateinteractively (ie, two-way) with any number or type of outsideelectronic devices, for example a cell phone (via a cell phone network)or laptops (via an internet server).

The wireless transceiver 30 is in the form of a cell phone chip (notshown) housed within the electronic control module 11 (or the housing3). The significant cost of installing a cell phone chip is mitigated bythe fact that the device 1 is reusable and has an indefinite lifetime.

The wireless transceiver 30 is able to transmit data to a third party orto another electronic device. For example, the wireless transceiver 30may transmit patient usage data to a medical practitioner or to a parentor care giver. It may do this by transmitting the data to a cell phonenetwork 31, and subsequently to an internet server 32 (and therefore toa mobile phone or laptop respectively).

The wireless transceiver 30 is also adapted to transmit the data in realtime. Alternatively, the wireless transceiver 30 may be adapted totransmit data at a predetermined time(s), or in response to when apredetermined condition eventuates, for example if too many doses ofmedicament have been dispensed in a set time period indicating that anexacerbation event may be imminent. An appropriate warning may then bemade to either the patient or a third party such as a parent or medialpractitioner.

The transceiver 30 is also able to wirelessly receive data orinstructions. For example, the transceiver 30 may be utilised to enablethe patient (or perhaps a third party) to send instructions from aremote location or electronic device to change one or more of thesettings of the device 1. The transceiver 30 may also be utilised toreceive outside instructions to sound an alert or alarm. For example, ifa third party such as a parent or medical practitioner had received datafrom the device 1 which indicated that a exacerbation was imminent, thatthird party may be able to transmit a warning to the device 1, forexample by the use of a laptop or mobile phone.

The LCD screen 15 may be utilised, if required, as a dose counterdisplay, for example for displaying the number of doses of medicamentremaining in the canister 5, or alternatively for displaying the numberof doses taken by the patient over a set time period.

Preferably, the dose counter display may be updated each time a dose ofmedicament is dispensed.

The device 1 may be used by the patient to serve as an absolute dosecounter. For example, the patient may utilise the user interface 13 tochoose this option and then enter the total number of doses remaining tobe dispensed by the medicament canister 5—with this number then beingdisplayed by the dose display counter on the LCD screen 15. After thedispensing of each dose of medicament by the inhaler 2, the dose counterdisplay will reduce the number of doses remaining by one.

The device 1 may also be used by the patient to serve as a non-absolutedose counter. For example, the patient may utilise the user interface 13to choose this option and then reset the dose display counter to zero.After the dispensing of each dose of medicament by the inhaler 2, thedose counter display will increase the number of doses taken by one.Because the device is reusable across a range of medicament inhalers 2or canisters 5, the patient may keep an ongoing total of the number ofdoses of medicament dispensed over a set period of time, rather thanjust in relation to one supply of medicament.

FIGS. 7 and 8 illustrate how the device 1 may be utilized with a priorart inhaler 37 which has a medicament canister 33 with an inbuiltmechanical dose counter. The prior art inhaler 37 is the GSK prior artdevice referred to previously. The canister 33 includes an absolute dosecounter display 34—which indicates that there are 10 doses remaining inthe canister 33. The canister 33 is adapted to fit within its owndedicated actuator 35.

FIG. 8 shows the device 1 from the rear, and with the prior art inhaler37 housed within the housing 3 of the device 1. The housing 3 isprovided with a cut-away portion 36 which enables the dose counterdisplay 34 to be viewable once the prior art inhaler 37 has been placedwithin the housing 3 of the device 1. An advantage associated with suchan embodiment is that the prior art inhaler 37 may continue to functionas an absolute dose counter with respect to the current canister ofmedicament 33. Furthermore, the device 1 may be utilised by the patientto act as a non-absolute dose counter (as described above), and for alength of time covering the use of many canisters 33. Hence, the patientmay obtain two useful sets of data—one relating to the patient usage inrelation to each canister 33 of medicament, and the second relating togeneral usage information over a significant (or predetermined) lengthof time.

FIGS. 9A-9C illustrate another embodiment of the present invention, foruse with a DPI inhaler 38.

The DPI inhaler 38 is in the form of a disk which includes a store ofdry powder (not shown) for the treatment of a respiratory disease suchas asthma. The inhaler 38 includes a powder release lever 39 and amouthpiece 40. As a skilled addressee would understand a portion 38 a ofthe DPI inhaler 38 must be rotated from a closed position to an openposition to reveal and provide access to the powder release lever 39 andthe mouthpiece 40 by the user. In normal use, the lever 39 is moved inthe direction indicated by arrow 41, and this releases a metered dose ofdry powder into an internal cavity (not shown) adjacent the mouthpiece40. The patient may then inhale the powder by sucking strongly throughthe mouthpiece 40.

Releasably attached to the inhaler 38 is a device, generally indicatedby arrow 42, for monitoring patient usage of the inhaler 38. FIG. 9Bshows the DPI inhaler in the closed position, where the mouthpiece andthe lever are not accessible. To reveal the mouthpiece 40 and the lever39, as shown in FIG. 9A, the patient moves the portion 38 a of theinhaler 38 in direction indicated by arrow 141, shown in FIG. 9B.

The device 42 includes a housing 43 which is substantially U-shaped andwhich is designed to slide over and fit snugly around a substantialportion of the inhaler 38. The housing 43 is also provided with a hinge46 to enable the housing 43 to hingedly open up into two halves in orderto be fitted to the inhaler 38, if so desired or required.

The housing 43 includes an optical dose counter (116) which is able todetermine when a dose of medicament has been dispensed from the inhaler38 by transmitting optical signals through the inhaler 38, and sensingmovement of the internal parts of the inhaler 38 during the dispensingof a dose of powder. The optical dose counter 116 includes a lighttransmitter(s) (not shown) and a light receiver(s) (not shown), bothhoused within the housing 43. In one embodiment, the light receiver(s)may be positioned substantially opposite the light transmitter(s) inorder to receive a substantially direct beam of light. In such anembodiment, the movement of part(s) within the inhaler during thedispensing of a dose may temporarily block the beam of light, thusenabling the dose counter to register that a dose of medicament has beendispensed.

In an alternative embodiment, the light transmitter(s) may transmit anormal beam of light, which will generally disperse outwardly from thepoint of transmission. The movement of part(s) within the inhaler duringthe dispensing of a dose will therefore affect the light signal, forexample by the light reflecting off the part(s) as they move. This willalter the intensity of light being received by the light receiver(s),thus enabling the dose counter to register that a dose of medicament hasbeen dispensed. In such an embodiment, it is not necessary that themoving part(s) actually block the light signal to enable a dose to bedetected and/or counted. Hence, the light transmitter(s) and lightreceiver(s) need not necessarily be positioned substantially oppositeeach other. It is also possible that the light transmitter(s) and lightreceiver(s) could be positioned next to each other or side by side.

Having regard to FIG. 9C, alternative positions of the optical dosecounter 116 are illustrated. In some embodiments, the lighttransmitter(s) and the light receiver(s) will be positionedsubstantially opposite each other. In other embodiments, the lighttransmitter(s) and the light receiver(s) may be positioned next to eachother. The device 42 also includes an electronic control module (notshown in FIG. 9A-9C, but also represented in the system block diagram ofFIG. 10) which works substantially the same as the electronic controlmodule associated with the pMDI inhaler 2. Furthermore, the housing 43includes a user interface which includes an LCD screen 44 andoperational buttons 45.

The device 42 only differs from the device 1 in its shape and design—inorder for the device 42 to be able to fit a DPI inhaler 38 as comparedto a pMDI inhaler 2. The device 42 may therefore have some or all of thesame features and operational capabilities as the device 1 describedpreviously in relation to the pMDI inhaler 2. For convenience therefore,a detailed description of the workings of the device 42 is notconsidered necessary, and the reader is instead referred to the detaileddescription previously provided in relation to the workings of thedevice 1 for use with the pMDI inhaler 2.

An advantage associated with the device (1, 42) generally is that it mayserve as both a patient compliance monitor (for example to monitorpatient compliance in relation to a medicament such as a preventer orcombination medicament) and also as a device to monitor patient usage ofan emergency drug such as a reliever. The patient (or a third party suchas a parent or medical practitioner) may therefore obtain important anduseful information relating to a patient's compliance generally, as wellas the ability to be forewarned of the possibility of an event such asan exacerbation event.

The invention may be particularly useful for use with large clinicaltrials, for example those used to determine whether a particularmedicament may have unwanted side effects. Such trials may include anumber of people in a trial group (those using the medicament beingtested) and a number of people in the control group (those not using themedicament being tested). There may be upwards of 3000 people in eachgroup, and the results of the clinical trial may be very important.Hence, it is imperative that the people running the trial know forcertain whether the trial group and/or control group has been taking themedicament as prescribed, and over the set time period of the trial(which may be many months). Because the present invention is reusable inrelation to each new container of medicament being tested, it may beused by each patient in the trial, for the entire duration of the trial.

The invention may also be useful as a diagnostic tool by a respiratoryspecialist for use with their patients. For example, a specialist may beunsure whether a patient has asthma or heart disease. The specialist maytherefore supply the device to a patient for use with asthma medicamentover a period of time and the usage information being used by thespecialist to diagnose the disease. Moreover, the patient may return thedevice to the specialist at the conclusion of the trial whereby it maybe supplied the next patient of the specialist.

The invention may also be useful as a self-diagnosis device for apatient. That is, a patient may use the device to self-monitor their ownpersonal usage and make conclusions or changes as a result.Alternatively, it may be used by a parent or care giver as a tool forascertaining if someone in their care has been taking their medicamentcorrectly, or otherwise.

This may be of particular advantage during clinical trials where theongoing monitoring of a patient is being undertaken over a considerabletime period, and perhaps whereby the patient changes medication half waythrough the trial.

While the embodiments described above are currently preferred, it willbe appreciated that a wide range of other variations might also be madewithin the general spirit and scope of the invention and/or as definedby the appended claims.

What is claimed is:
 1. A device for monitoring patient usage of amedicament inhaler having an exterior surface, the medicament inhalerbeing configured to deliver doses of medicament, the medicament inhalerincluding a medicament container and at least one moving part(s)configured to move to enable delivery of at least one dose of medicamentfrom the medicament container, the device comprising: a) a housingreleasably attachable to the exterior surface of the medicament inhaler,the housing being usable on the medicament inhaler without requiring anyphysical modifications to the medicament inhaler; and b) an optical dosecounter coupled to the housing, the optical dose counter beingconfigured to determine when a dose of medicament is being dispensed bythe medicament inhaler by transmitting electromagnetic signals directedtowards at least a portion of the medicament inhaler from a positionoutside of the outermost surface of the medicament inhaler, the opticaldose counter including: i) at least one electromagnetic signaltransmitter configured to transmit an electromagnetic signal from aposition outside of the outermost surface of the medicament inhaler; ii)at least one electromagnetic signal receiver configured to receive theelectromagnetic signal from a position outside of the outermost surfaceof the medicament inhaler; and iii) an electronic control moduleassociated with the housing, the electronic control module including, orbeing in communication with the optical dose counter, the electroniccontrol module being adapted to monitor and/or store data relating topatient usage of the medicament inhaler, wherein, when a first movingpart of the at least one moving part(s) of the medicament inhaler is ina rest position, the electromagnetic signal emitted from the transmitterincludes a beam directed towards a first portion of the medicamentinhaler and the electromagnetic signal receiver detects a restcharacteristic of the electromagnetic signal; and when the first movingpart is rotated to a dose-dispensing position, the electromagneticsignal emitted from the transmitter includes a beam directed towards atleast a second portion of the medicament inhaler and the electromagneticsignal receiver detects a dose-dispensing characteristic of theelectromagnetic signal, wherein the electronic control module detects achange between the rest characteristic and the dose-dispensingcharacteristic of the electromagnetic signal to determine that a dose ofmedicament is being dispensed.
 2. The device for monitoring patientusage of the medicament inhaler as claimed in claim 1, wherein thechange between the rest characteristic and the dose-dispensingcharacteristic is a change in intensity of the electromagnetic signal.3. The device for monitoring patient usage of the medicament inhaler asclaimed in claim 1, wherein the change between the rest characteristicand the dose-dispensing characteristic is a change in a direction of theelectromagnetic signal.
 4. The device for monitoring patient usage ofthe medicament inhaler as claimed in claim 1, wherein at least one ofthe first portion and the second portion includes a location at one ofthe moving parts of the at least one moving parts of the medicamentinhaler.
 5. The device for monitoring patient usage of the medicamentinhaler as claimed in claim 4, wherein at least one of the first portionand the second portion includes a location at the first moving part. 6.The device for monitoring patient usage of the medicament inhaler asclaimed in claim 1, wherein the transmitter beam penetrates through themedicament inhaler.
 7. The device for monitoring patient usage of themedicament inhaler as claimed in claim 6, wherein at least one of thefirst portion and the second portion includes a location within themedicament inhaler.
 8. The device for monitoring patient usage of themedicament inhaler as claimed in claim 1, wherein at least one of thefirst portion and the second portion includes a location on theoutermost surface of the medicament inhaler.
 9. The device formonitoring patient usage of the medicament inhaler as claimed in claim1, wherein the rotation of the first moving part from the rest positionto the dose-dispensing position prepares the medicament container fordelivery of the least one dose of medicament.
 10. The device formonitoring patient usage of the medicament inhaler as claimed in claim1, wherein the medicament inhaler includes at least two moving parts,the first moving part and a second moving part, that are each configuredto move to enable delivery of the at least one dose of medicament fromthe medicament container.
 11. The device for monitoring patient usage ofthe medicament inhaler as claimed in claim 10, wherein the second movingpart is the medicament container.
 12. The device for monitoring patientusage of the medicament inhaler as claimed in claim 11, wherein one ofthe first portion and the second portion of the medicament inhalerincludes at least a portion of the second moving part.
 13. The devicefor monitoring patient usage of the medicament inhaler as claimed inclaim 10, wherein the rotation of the first moving part from the restposition to the dose-dispensing position moves the second moving partinto a position to deliver the least one dose of medicament.
 14. Thedevice for monitoring patient usage of the medicament inhaler as claimedin claim 1, wherein the electronic control module further includes aprocessor and/or controller to enable the electronic control module toperform operations on the data.
 15. The device for monitoring patientusage of the medicament inhaler as claimed in claim 1, wherein thehousing is provided with a hinged portion which, when open, allows themedicament inhaler to be placed within the housing, and which, whenclosed, serves to retain the medicament inhaler within the housing. 16.The device for monitoring patient usage of the medicament inhaler asclaimed in claim 1, wherein the optical dose counter utilizes infraredlight.
 17. The device for monitoring patient usage of the medicamentinhaler as claimed in claim 1, wherein the optical dose counter utilizesvisible spectrum light.
 18. The device for monitoring patient usage ofthe medicament inhaler as claimed in claim 1, wherein the electroniccontrol module includes, or is in communication with, a wirelesstransmitter to enable the wireless transmitting of data relating topatient usage of the medicament inhaler.
 19. The device for monitoringpatient usage of the medicament inhaler as claimed in claim 18, whereinthe electronic control module further includes, or is in communicationwith, a wireless receiver to enable the wireless receipt of data orinstructions from a third party.
 20. The device for monitoring patientusage of the medicament inhaler as claimed in claim 1, wherein themedicament inhaler is a Dry Powder Inhaler.
 21. The device formonitoring patient usage of the medicament inhaler as claimed in claim1, wherein the housing includes a first side and a second side arrangedto receive the medicament inhaler there between.
 22. The device formonitoring patient usage of the medicament inhaler as claimed in claim21, wherein the at least one electromagnetic signal transmitter and theat least one electromagnetic receiver are both positioned on one of thefirst side or the second side of the device.
 23. The device formonitoring patient usage of the medicament inhaler as claimed in claim20, wherein the at least one electromagnetic signal transmitter ispositioned on the first side or the second side and the at least oneelectromagnetic receiver is positioned on the opposing first side orsecond side.
 24. The device for monitoring patient usage of themedicament inhaler as claimed in claim 1, wherein the device furthermonitors a state of deterioration of an interior surface of themedicament inhaler.
 25. The device for monitoring patient usage of themedicament inhaler as claimed in claim 1, wherein the housing includesfurther sensors for monitoring the delivery of at least one or moredoses of medicament provided by the medicament inhaler.
 26. The devicefor monitoring patient usage of the medicament inhaler as claimed inclaim 25, wherein the electronic control module is configured to detectthe dose of medicament dispensed based on at least: a) a signalgenerated by the signal receiver indicating that the dose of medicamentis being dispensed, and b) a signal generated by one of the furthersensors, wherein the further sensors is an audio sensor indicating thatthe dose of medicament is being dispensed.
 27. The device for monitoringpatient usage of the medicament inhaler as claimed in claim 1, whereinat least a portion of the housing is translucent or transparent.
 28. Amedicament inhaler having an exterior surface, and being adapted todeliver doses of medicament, the medicament inhaler comprising: amedicament container and at least one moving part(s) configured to moveto enable delivery of at least one dose of medicament from themedicament container, and a device for monitoring patient usage of themedicament inhaler, the device including: 1) a housing releasablyattachable to the exterior surface of the medicament inhaler, thehousing being usable on the medicament inhaler without requiring anyphysical modifications to the medicament inhaler; and 2) an optical dosecounter included within the housing, the optical dose counter beingconfigured to determine when a dose of medicament is being dispensed bythe medicament inhaler by transmitting electromagnetic signals directedtowards the medicament inhaler from a position outside of the outermostsurface of the medicament inhaler, the optical dose counter including:i) at least one electromagnetic signal transmitter configured totransmit an electromagnetic signal from a position outside of theoutermost surface of the medicament inhaler; ii) at least oneelectromagnetic signal receiver configured to receive theelectromagnetic signal from a position outside of the outermost surfaceof the medicament inhaler; and iii) an electronic control moduleassociated with the housing, the electronic control module including, orbeing in communication with the optical dose counter, the electroniccontrol module being adapted to monitor and/or store data relating topatient usage of the medicament inhaler, wherein, when a first movingpart of the at least one moving part(s) of the medicament inhaler is ina rest position, the electromagnetic signal emitted from the transmitterincludes a beam directed towards a first portion of the medicamentinhaler and the electromagnetic signal receiver detects a restcharacteristic of the electromagnetic signal; and when the at least onemoving part of the medicament inhaler is in a dose-dispensing position,the electromagnetic signal emitted from the transmitter comprises a beamdirected towards at least a second portion of the medicament inhaler andthe electromagnetic signal receiver detects a dose-dispensingcharacteristic of the electromagnetic signal, wherein the electroniccontrol module detects a change between the rest characteristic and thedose-dispensing characteristic of the electromagnetic signal todetermine that a dose of medicament is being dispensed, and the at leastone moving part includes a rotating part configured to rotate from therest position to the dose-dispensing position.
 29. A method of treatinga respiratory disease comprising: 1) delivering doses of medicament to apatient using a medicament inhaler having an exterior surface, themedicament inhaler being adapted to deliver doses of medicament to apatient, the medicament inhaler including a medicament container and atleast one moving part(s) configured to move to enable delivery of atleast one dose of medicament from the medicament container; and 2)monitoring patient usage of the medicament inhaler using a device formonitoring patient usage of the medicament inhaler, the deviceincluding: a) a housing releasably attachable to the exterior surface ofthe medicament inhaler, the housing being usable on the medicamentinhaler without requiring any physical modifications to the medicamentinhaler; and b) an optical dose counter included within the housing, theoptical dose counter being configured to determine when a dose ofmedicament is being dispensed by the medicament inhaler by transmittingelectromagnetic signals directed towards the medicament inhaler from aposition outside of the outermost surface of the medicament inhaler, theoptical dose counter including: i) at least one electromagnetic signaltransmitter configured to transmit an electromagnetic signal from aposition outside of the outermost surface of the medicament inhaler; ii)at least one electromagnetic signal receiver configured to receive theelectromagnetic signal from a position outside of the outermost surfaceof the medicament inhaler; and iii) an electronic control moduleassociated with the housing, the electronic control module including, orbeing in communication with the optical dose counter, the electroniccontrol module being adapted to monitor and/or store data relating topatient usage of the medicament inhaler, wherein, when a first movingpart of the at least one moving part of the medicament inhaler is in arest position, the electromagnetic signal emitted from the transmitterincludes a beam directed towards a first portion of the medicamentinhaler and the electromagnetic signal received from the receiverdetects a rest characteristic of the electromagnetic signal; and whenthe first moving part is rotated to a dose-dispensing position, theelectromagnetic signal emitted from the transmitter includes a beamdirected towards at least a second portion of the medicament inhaler andthe electromagnetic signal received from the receiver detects adose-dispensing characteristic of the electromagnetic signal, whereinthe electronic control module detects a change between the restcharacteristic and the dose-dispensing characteristic of theelectromagnetic signal to determine that a dose of medicament is beingdispensed.
 30. The method of treating a respiratory disease as claimedin claim 29, further including moving the first moving part of themedicament inhaler from the rest position to the dose-dispensingposition to prepare the medicament container for delivery of the leastone dose of medicament and delivering the at least one dose ofmedicament to the patient.